Effects of Exercise and Metformin on Methylglyoxal Levels in Prediabetic Individuals

September 17, 2024 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is no comparative study in the literature evaluating the effects of exercise and metformin on MGO in prediabetic patients. The aim of this study is to compare the effects of exercise, standard lifestyle changes and metformin on MGO in prediabetic individuals.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Üsküdar, İstanbul, Turkey, 34660
        • Sultan 2. Abdulhamid Han Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who were newly diagnosed with prediabetes by Oral Glucose Tolerance Test (OGTT) and/or HbA1C,
  • who were assessed as physically inactive (Level 1) according to the International Physical Activity Questionnaire
  • who had sufficient motivation to participate in the exercise program (assessed by one-on-one interviews conducted by the researchers),
  • who were deemed suitable to participate in the exercise program after a cardiac examination by a cardiologist (with resting electrocardiogram and questioning of cardiac symptoms, and advanced tests such as exercise electrocardiogram test when necessary),
  • who had the same weight (±2.5 kg) for 6 months before participating in the study.

Exclusion Criteria:

  • having a serious medical condition that would prevent the person from participating in the exercise study (e.g. advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.),
  • having used metformin for 6 months before the study, having cardiovascular disease,
  • heart failure, cancer, having a BMI <19 kg/m2, receiving hormone replacement therapy,
  • having a life expectancy of less than 1 year, being HIV positive, substance use,
  • functional dependence, having an orthopedic disease that prevents physical activity,
  • having cognitive impairment and other diseases that would affect the study results (respiratory diseases, muscle diseases, non-alcoholic fatty liver disease, etc.),
  • using medications or supplements that would affect the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aerobic Exercise
12 week aerobic exercise
Behavioral: Exercise
Aerobic exercise (moderate intensity) at 50-70% of maximum heart rate for 60 minutes, 3 days a week for 12 weeks
Experimental: Metformin
Metformin 2*1 given
Other: Metformin
Patients who started Metformin 2*1
No Intervention: Control
Only routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MGO
Time Frame: 1 week
Methylgloxal level
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2021

Primary Completion (Actual)

December 7, 2022

Study Completion (Actual)

December 7, 2022

Study Registration Dates

First Submitted

September 13, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEGS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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